NEW YORK – Fluidigm this week announced that the Central Drugs Standard Control Organisation (CDSCO) in India has licensed importation and sale of its Advanta Dx SARS-CoV-2 RT-PCR Assay, one of the first saliva-based tests to be licensed for COVID-19 testing in India. The license granted to Premas Life Sciences, a Delhi-based life sciences distribution company, enables use of the test in laboratories approved by the Indian Council of Medical Research or a relevant state or central government. Fluidigm obtained Emergency Use Authorization from the US Food and Drug Administration for its Advanta Dx SARS-CoV-2 RT-PCR assay in August.
Centogene said on Wednesday that it has expanded its 2019 partnership with PTC Therapeutics for aromatic L-amino acid carboxylase (AADC) deficiency testing. Centogene will now provide genetic testing and 3-OMD biomarker analytics to identify patients with AADC deficiency in new geographic areas, including countries in Europe, the Middle East, and Latin America. In addition, the firm will make its testing and biomarker analytics available for patients in the REVEAL CP study, a global screening study designed to determine the prevalence of AADC deficiency in patients with cerebral palsy of unknown cause. Financial or other terms of the expanded agreement were not disclosed.
Ginkgo Bioworks said this week that it will receive a loan of up to $1.1 billion from the US International Development Finance Corporation (DFC) enabling the company to expand ongoing biosecurity efforts, including optimizing COVID-19 vaccine manufacturing, delivering widespread testing, and building infrastructure to help identify, prevent, and respond to future pandemics. Under the Defense Production Act, DFC, in coordination with the US Departments of Defense and Health and Human Services, supports domestic initiatives that will aid in the fight against COVID-19 in the US. Using the loan, Ginkgo said it will continue applying its platform to optimize manufacturing of critical raw materials required for production of nucleic acid vaccines against COVID-19. It will also continue programs such as Concentric by Ginkgo, a set of products focused on large-scale SARS-CoV-2 testing.
Applied DNA Sciences said that the US Food and Drug Administration has granted it an Emergency Use Authorization amendment to expand the installed base of RT-PCR platforms that can process the company's Linea COVID-19 Assay Kit. The EUA amendment authorizes the kit to now be used on Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx Real-Time PCR System (ABI 7500) in addition to Thermo Fisher's QuantStudio Dx and QuantStudio 5 Real-Time PCR systems. The ABI 7500 has the capacity to perform 400 to 800 tests in 24 hours and is found in the majority of clinical laboratories nationally, Applied DNA Sciences noted.
In addition, Applied DNA Sciences disclosed that an inspection report from the State of New York Department of Health following its initial inspection of Applied DNA Clinical Laboratories (ADCL) on Oct. 7 highlighted deficiencies in ADCL's clinical standard of practice at the time of inspection that require remediation prior to the submission of a reinspection request. The company expects to complete remediation actions during the first calendar quarter of 2021. In the interim, ADCL's SafeCircle platform, its pooled COVID-19 surveillance testing program that does not require CLEP-CLIA certification, is leveraging infrastructure designated for diagnostic testing to support SafeCircle clients and Applied DNA's internal surveillance testing program for employees.
Toronto-based molecular diagnostic company StageZero Life Sciences this week reported revenues of $1.5 million for the third quarter ended Sept. 30.
During the quarter, the company announced it obtained preferred lab status from the government of Barbados for COVID-19 testing aimed at allowing air travel to commence. StageZero added that in Q3, it also expanded its laboratory footprint and automation, introduced a respiratory panel, and introduced at-home collection for PCR testing using saliva samples.
Its partner, Ichor Blood Services, announced an expansion of COVID-19 testing involving an agreement with the state of Hawaii and the initiation of testing for travel to China. StageZero conducts testing at a high complexity CLIA-certified lab in Richmond, Virginia.
At the end of Q3, the firm had $1.8 million in cash.
Becton Dickinson said this week that its board has declared a quarterly dividend of $.83 per share of its common stock, an increase of 5.1 percent from the prior quarter. The dividend will be payable on Dec. 31, 2020 to shareholders of record on Dec. 10.
Co-Diagnostics said this week that India's Central Drugs Standard Control Organization has cleared the company's joint venture, CoSara Diagnostics, to manufacture and sell the Saragene COVID-19 2-gene multiplex RT-PCR test kit.
CoSara Dx is a JV between Co-Diagnostics and Synbiotics Limited established in 2017 to manufacture and sell assays in India.
The Saragene test kit is for the qualitative detection of the SARS-CoV-2 virus and uses Co-Diagnostics' CoPrimer technology. It is based on a test originally designed by the Salt Lake City-based firm called the Logix Smart SARS-CoV-2 multiplex test. Both tests target two gene biomarkers of the SARS-CoV-2 genome, the RdRp and E genes, to identify the presence of the virus.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.